NCT03652818

Dental Pain Study of Analgesics in Patients Undergoing Molar Removal

Randomized, Double-blind, Parallel Group, Single-center, Placebo-controlled Study to Evaluate Efficacy and Safety of Analgesic Combo in Prevention and Treatment of Post-surgical Dental Pain in Healthy Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Nevakar, Inc. · Industry
• Sex: All
• Age: 17 Years – 55 Years
• Healthy volunteers: Accepted

Summary

* Accessing the efficacy and safety of pregabalin when used alone and in combo with acetaminophen in a dental pain model. * To test whether pre-operative dose of pregabalin increases the time to significant post-operative pain (NRS ≥ 5), and hence time to first analgesia consumed post-operatively.

Detailed description

This is a 5 arm randomized, double-blind, parallel group, single-center, placebo-controlled study to evaluate the efficacy and safety of pregabalin-acetaminophen combination in the prevention and treatment of post-surgical dental pain in healthy patients. Subjects in every treatment arm will receive a dose 60 min prior to surgery. It is not required to receive a post-operative dose if patient does not feel pain at a scale of NRS≥ 5. Dose 2 will be given post-surgically when patients report at least moderate pain on the categorical scale and a score of ≥5 on 0-10 PI-NRS. Subsequent to dose 2, patients can request rescue analgesic at any time.

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	Pre-Op pregabalin	Pre-op pregabalin will be administered 60 min prior to surgery.
DRUG	Pre-Op Placebo 1	Placebo 1 will be administered 60 min prior to surgery.
DRUG	Post-Op pregabalin	Post-op pregabalin will be administered Post-operatively.
DRUG	Post-Op Placebo 1	Placebo 1 will be administered post-operatively.
DRUG	Post-Op Placebo 2	Placebo 2 will be administered post-operatively.
DRUG	Post-Op acetaminophen	Acetaminophen will be administered Post-operatively.

Timeline

• Start date: 2018-06-15
• Primary completion: 2018-09-20
• Completion: 2018-09-20
• First posted: 2018-08-29
• Last updated: 2021-11-23
• Results posted: 2021-11-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study